Organovo Holdings (ONVO.US) announced the positive results of its phase 2 trial of the drug FXR314 for the treatment of patients with metabolic function-related steatohepatitis (MASH).
The Zhitong Finance App learned that on April 16, Organovo Holdings (ONVO.US) announced the positive results of the phase 2 trial of its drug FXR314 for the treatment of patients with metabolic function-related steatohepatitis (MASH). The study results showed that compared with placebo, patients treated with FXR314 had significantly lower liver fat content compared to baseline.
The trial announced this time was a 16-week randomized, placebo-controlled, multicenter phase 2 trial. The analysis showed that compared with the baseline, the liver fat content of FXR314 subjects decreased statistically significantly. At the end of treatment, the minimum square average percentage of liver fat in the 3 mg FXR314 group decreased by 22.8% (p=0.0010), the 6-mg FXR314 patients decreased by 17.5% (p=0.0267), while the placebo group decreased by 6.1%.
Furthermore, the proportion of participants in the 3 mg and 6 mg FXR314 groups who had a magnetic resonance imaging proton density fat fraction (MRI-PDFF) reduction of > 30% was 29.2% (p=0.0023) and 32.2% (p=0.0020), respectively, compared with 9.5% in the placebo group. The researchers observed improvements in hepatocyte damage and liver function in patients based on serological measurements, and there was no evidence that liver fibrosis worsened.